Suppliers of herbal medicines are being reminded that unlicensed and unregistered products can no longer be sold to consumers and must be cleared from shelves.
From today, herbal companies and retailers may only sell products that have a traditional herbal registration (THR) or product license (PL).
The rules also apply to traditional Chinese medicines.
Dr Linda Anderson, from the Medicines and Healthcare products Regulatory Agency (MHRA) Licensing Division, says in a statement: “The aim of the THR scheme is to give people access to traditional herbal medicines that are safe, of good quality and have information on how to use the product correctly.
“The public should only buy herbal medicines that they know have met standards which can be identified by the THR or PL number on the product. Most of the THR products also have the THR logo which can easily be identified on the packaging.
‘Not always safe’
“Natural doesn’t always mean safe. Some unlicensed herbal medicines can cause serious side effects or may interact with other medicines that a patient is taking.”
For those manufactured herbal medicines that were on the UK market before April 2011, when the traditional herbal registration scheme was implemented, the MHRA allowed retailers to ‘sell through’ their stock on the basis that they would be sold within the average 18 to 24 months shelf-life of these products.
This transitional period also allowed manufacturers additional time to bring their production up to the required standards to meet the new requirements. Companies can submit applications to the THR scheme at any time once they are able to meet the required standards.
This sell through period has now ended and companies must ensure that they comply with the legislation and remove any unlicensed herbal medicines from shelves.
The MHRA says that over 300 products are now registered under the THR scheme. However, unlike licensing for mainstream medicines, registration does not mean a herbal remedy has been tested and proven to actually work.
Dr Anderson adds: “People also need to be aware that not all of the products they are using, fall under the MHRA’s licensing system. A herbal practitioner is allowed to make up an individual preparation following a consultation. And other products can legally be sold as foods, cosmetics or general consumer products.”
‘Regulatory limbo’
Commenting on the changes in an emailed statement, Dee Atkinson, PR director at the National Institute of Medical Herbalists, says practising medical herbalists are now in “a regulatory limbo”.
She tells us: “Professional herbalists make up and use a wide range of herbal medicines and in many cases have products made specifically for their patients. These products are unlicensed and until we have regulation of the herbal practitioner, they sit uncomfortably outside of the regulatory frame work.
“The National Institute of Medical Herbalists – as the UK’s largest professional body of Western trained herbalists – urges the Government to move forward the Statutory Regulation of Herbal Practitioners, which is in the interests of the public, the practitioner and health service.
“One in four people has used herbal medicine and many GPs and health care providers have patients who use herbal medicines. Statutory Regulation will give increased confidence and safety to all and ensure that the patient has continued access to their herbal medicines.”
SOURCES:
Medicines and Healthcare products Regulatory Agency (MHRA).
Dee Atkinson, PR director, National Institute of Medical Herbalists.
‘Traditional herbal remedies’,
